The Laboratory Supervisor works under the direction of the Laboratory Medical Director and implements the laboratory policies and procedures. For the purposes of the Clinical Laboratory Improvement Act of 1988 (CLIA-88), the laboratory supervisor meets the qualifications and fulfills the responsibilities of the following personnel (as defined in the Federal Register, Vol. 57, No. 40, Subpart M, p. 7172 – 7183, published 02/28/92): General Laboratory Supervisor, Technical Supervisor of the specialty of Microbiology (subspecialty of Bacteriology), Technical Supervisor of Diagnostic Immunology, Technical Supervisor of Chemistry, and Technical Supervisor of Hematology. The Laboratory Supervisor must also be able to function as a testing person, and must meet the qualifications and assume the responsibilities of testing personnel in high complexity testing laboratories. In addition, the laboratory manager assumes the responsibility for completing duties assigned to the Laboratory Medical Director as defined in Subpart M, section 493.1445 (e), 3, 4, 5, 6, 7, 12, 13, and 14.
Recommended to have earned a Bachelor’s degree in a chemical, physical or biological science or medical technology from an accredited institution. Have at least 4 years of laboratory experience in high complexity testing in the laboratory specialties of Microbiology (subspecialty Bacteriology), Clinical Chemistry, Hematology and Diagnostic Immunology.
Professional certification as a Medical Technologist [MT (ASCP)] with a current certificate is required. Professional certification acquired through written examination that is equivalent to ASCP certification will be considered from the following agencies/societies: National Certification Agency (NCA), American Medical Technologists (AMT) or the International Society of Clinical Laboratory Technologists (ISCLT) and MT (HEW).
Have at least 3 years supervisory experience in a clinical laboratory (only hospital or medical clinic laboratories are considered clinical laboratories. Laboratories such as toxicology, forensic, veterinarian, University, manufacturing, or research laboratories are usually not considered clinical in nature.) Experience acquired in a clinical laboratory as a Laboratory Manager, Laboratory Supervisor, Laboratory Administrative Director, Chief Technologist of a clinical laboratory, laboratory section head or laboratory shift supervisor would be considered appropriate.
This employee must be able to demonstrate the knowledge and skill necessary to provide care appropriate to the age of the patients served in his/her assigned unit. The individual must demonstrate knowledge of the principles of growth and development over the life span (e.g., pediatric/adult/geriatric) and possess the ability to assess data reflective of the patient’s status and interpret the appropriate information needed to identify each patient’s requirements relative to his/her age specific needs, and to provide the care needed as described in the assigned unit’s policies and procedures.
The individual must be able to work with and care for people of all cultures.
The general laboratory supervisor is responsible for the day-to-day supervision or oversight of the laboratory and personnel performing testing and reporting test results.
The general laboratory supervisor must be accessible to testing personnel at all times testing is performed to provide on-site, telephone, or electronic consultations to resolve technical problems in accordance with policies and procedures. The general laboratory supervisor must be on-site when high complexity testing is performed by individuals who are not qualified to perform high complexity testing without supervision (See Federal Register Vol. 57, Number 40, Subpart M, Section 493-1489 (b) (4), p. 7183, published 02/02/92).
Responsible for writing and maintaining Laboratory procedures
The general laboratory supervisor is responsible for:
Monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained;
Assuring that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications;
Ensuring that patient results are not reported until all corrective actions have been taken and the test system is properly functioning;
Providing orientation to all testing personnel;
Annually evaluating and documenting the performance of all testing personnel.
The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however the technical supervisor must be accessible to the laboratory to provide on-site, telephone or electronic consultation.
Selection of test methodologies that are appropriate for the clinical use of the test results, establishment of test performance, characteristics, including the precision and accuracy of each test and test system, and verification of the test procedures performed.
Enrollment and participation in an HHS-approved proficiency testing program commensurate with the services offered.
Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analyses and reporting of test results.
Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of laboratory services performed.
Evaluating the competency of all testing personnel and assuring that the staff maintains their competency to perform test procedures and report test results promptly, accurately and proficiently.
Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens, and annually thereafter, unless changes in method or instrumentation dictate the need for more frequent re-evaluation.
Test methodologies selected have the capability of providing the quality of results required for patient care;
Verification procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method; and
Laboratory personnel are performing the methods as required for accurate and reliable results.
Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed and that
The proficiency testing samples are performed according to federal regulations (CLIA-88 regulation, subpart H);
The results are returned within the timeframes established by the proficiency testing program;
All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory’s performance and to identify any problems that require corrective action; and
An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory.
Ensure that quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.
Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.
Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance characteristics are identified, and that patient results are reported only when the system is functioning properly.
Ensure that prior to testing patient’s specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.
Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.
Testing personnel are responsible for specimen processing, test performance, and for reporting test results.
Each individual performs only those high complexity tests that are authorized by the Laboratory Medical Director and require a degree a skill commensurate with the individual’s education, training or experience, and technical abilities.
Each individual performing high complexity testing must:
Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results.
Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
Adhere to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.
Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance
Be capable of identifying problems that may adversely affect test performance or reporting of test results. Must either correct the problems or immediately notify the Laboratory Supervisor, Technical Supervisor, Consulting Pathologist or the Laboratory Medical Director.
Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.